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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Movement and Compressions System (MAC) - B547RF14200

MAC Strap-Standard
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14208 ()
  • B547RF14200 ()
  • B547RF1440209 ()

  • Length: 565 Millimeter
RF1420

  • Intermittent venous compression system

UE BioSleeve - B3673350

Cutaneous Electrode Garment Released as revision 5 on 2017-11-28
AXIOBIONICS
5
In Commercial Distribution

  • B3673350 ()
  • B3673340 ()
33

  • Transcutaneous electrical stimulation electrode, single-use

N/A - 00810050243308

KIT, SMALL, "B". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052)
DOMICO MED-DEVICE, LLC
5
In Commercial Distribution

  • 00810050243308 ()


  • Multifunction body cushion
  • Radiological general body-part positioner

OTS Hip Guide SW - 07350137520029

No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520029 ()
20-100

  • Electromagnetic/optical surgical navigation device tracking system

OTS Hip Plan - 07350137520005

No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520005 ()
20-101

  • Surgical planning/navigation-enhancement system

Radmedix AccuVue+ - 00810035220379

A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
RADMEDIX, LLC
5
In Commercial Distribution

  • 00810035220379 ()


  • Radiology DICOM image processing application software

VasQ - 07290016063356

External support for vascular access arteriovenous fistulas
LAMINATE MEDICAL TECHNOLOGIES LTD
5
In Commercial Distribution

  • 07290016063356 ()
FG0035

  • Arteriovenous fistula extraluminal mesh-sleeve

Chemoment - 06976009585555

No Description
Chemoment Materials Co., Ltd.
5
In Commercial Distribution

  • 06976009585555 ()


  • Silicone dental impression material

moorFLPI-2 Review PC Software - 15060484490119

moorFLPI-2 Review PC Software V5
MOOR INSTRUMENTS LIMITED
5
In Commercial Distribution

  • 15060484490119 ()


  • Cutaneous microcirculation laser Doppler imaging device

ARROW - 30801902093951

AutoCAT2WAVE(R) IABP, Refurbished
TELEFLEX INCORPORATED
IPN001096
In Commercial Distribution

  • 30801902093951 ()
  • 00801902093950 ()
IAP-0500IX

  • Intra-aortic balloon pump
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